RECRUITING

A Comparative Study to Evaluate a Novel Algorithm As a Diagnostic Aid for ADHD in Youth Ages 6-17.

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Conditions

ADHD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to demonstrate the accuracy of the MT1 algorithm using the MindTension biometric sensor device as a diagnostic aid for healthcare providers in diagnosing ADHD in youth ages ≥ 6 to ≤17 years.

Official Title

A Prospective Comparative Study to Evaluate a Novel Algorithm Using Data Derived from a Non-Invasive Digital Biomarker As a Diagnostic Aid for ADHD in Youth Ages 6-17.

Quick Facts

Study Start:2024-06-02
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06728969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Parent provision of signed and dated informed consent form
  2. 2. Child stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Any gender, aged 6 to 17 years
  4. 4. Stimulant naïve or willing to wash out of stimulant for 3 days (approximately 72 hours) prior to testing with biometric and performance devices (MindTension + TOVA)
  5. 5. ADHD Group: Diagnosed with symptoms consistent with ADHD as determined by Mini Kid + an ADHD-RS score of 1.5SD above mean for age and sex
  6. 6. Control group: No diagnosable disorder on the Mini kid, and an ADHD-RS score within 1SD of the mean for age and sex.
  1. 1. Current use of psychotropic medications that cannot be washed out in 3 days (approximately 72 hours)
  2. 2. Known current seizure disorder (history of febrile seizure allowed).
  3. 3. Presence of specific devices (e.g., cardiac pacemaker) that may interfere with the MindTension monitor
  4. 4. IQ\<70 by clinician judgment
  5. 5. Meeting FULL criteria for current PTSD, GAD, MDD, or any lifetime diagnosis of ASD, Bipolar disorder, or psychotic disorder that was, in the opinion of the investigator, correctly obtained. May have symptoms of anxiety or dysthymia/depression not meeting criteria for a full disorder, or disorders such as simple phobia
  6. 6. Deaf or hearing impaired, since this will make it difficult to hear and respond to the auditory stimuli.
  7. 7. Inability to complete the assessments.
  8. 8. Any other concerns in the judgment of the PI.

Contacts and Locations

Study Contact

Jeffrey Newcorn, MD Professor
CONTACT
212-659-8705
jeffrey.newcorn@mssm.edu
Beth Krone, PhD, MS
CONTACT
212 241 8012
beth.krone@mssm.edu

Principal Investigator

Jeffrey Newcorn, MD Professor
PRINCIPAL_INVESTIGATOR
Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: MindTension

  • Jeffrey Newcorn, MD Professor, PRINCIPAL_INVESTIGATOR, Director, Division of ADHD and Learning Disorders Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-02
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-06-02
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • ADHD